By SABRINA TAVERNISE
Published: October 22, 2012
A year before people began dying of meningitis
caused by a tainted drug from a compounding pharmacy in Massachusetts, the Food
and Drug Administration worried that compounders across the country might be
selling another substandard drug, one possibly made with unapproved Chinese
ingredients.
But when the F.D.A. began seeking samples to test, the
trade group representing compounding pharmacists went on the offensive. Instead
of encouraging members to help the agency determine if the injectable drug, used
to reduce the risk of premature birth, was substandard, the group tutored
pharmacists on how to sidestep requests.
In an e-mail to members, the International
Academy of Compounding Pharmacists suggested that they respond to any
request for samples by saying: “We do not compound or distribute ‘samples’ of
any of our prescription medications to anyone.” And if a compounded drug was on
the premises, the trade group added, a pharmacist should say it was awaiting
pickup by a patient.
A spokesman for the trade group said the instructions
were intended to guard against unauthorized release of samples to corporate
competitors and not to hinder the F.D.A. investigation. But the memo is
emblematic of the industry’s frequent and often successful attempts to fend off
regulators at a time when concerns are growing about the quality of compounded
drugs and the uncertain provenance of their ingredients, some of which originate
in China and flow through various repackagers and middlemen with little
scrutiny, according to interviews with health experts and government records.
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